56 Financial Regulations jobs in South Africa

Reference: DBN -SS-4

Job Purpose:
Lead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs.

Ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.

Key Responsibilities:

1. Manage work streams for- and report on the assigned group of portfolios
2. Assisting with internal product queries from relevant departments
3. Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders
4. Establish regulatory priorities and allocate resources and workloads
5. Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
6. Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to:
1. Develop regulatory strategies and implementation plans for the preparation and submission of new products
2. Conduct dossier due diligence to ensure all data gaps are addressed
3. Prepare the registration applications for submission to the regulatory authorities
4. Work in collaboration with NBD to assess regulator’s submissions requirements
5. Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
6. Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
7. Internal training and mentoring
8. Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
9. Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
10. Manage activities such as internal audits or regulatory agency inspections
11. Ensure alignment of personal and company values

Requirements:

1. Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
2. Minimum of 5 years’ experience in Regulatory Affairs, preferably in human medicines. Demonstrated experience across the product development, commercialization and maintenance lifecycle
3. Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
4. Sound project management capabilities
5. Proven ability to consistently deliver to quality, time and cost standards Professional people management experience

Competencies:

1. Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
2. IT skills
3. Leadership skills, management of personnel resources
4. Ability to prioritise and work to tight deadlines
5. Systems and operations analysis
6. Active learning
7. Strategic thinking
8. Ability to cope with a high degree of complexity and change
9. Cross Functional skills: Ability to network, liaise and negotiate with others
10. Ability to set standards and objectives and monitor progress
11. Complex problem solving and decision-making skills
12. Customer relationships
13. Development of people
14. Must demonstrate responsibility, excellence and collaboration and align with Company values

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on

Should you receive no feedback within 7 days, please accept your application as unsuccessful.

HR Services, Recruitment & Selection

Overview

Job title: Regulatory Affairs Coordinator

Job Location: Western Cape, Cape Town

Deadline: October 17, 2025

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Reports to: Senior Research and Development Manager

• Compliancy to International and Domestic Regulations: Ensure all I&J products produced and purchased are compliant with current International and Local regulations as well as mandatory and voluntary information including claims & endorsements.
• Ensuring all labelling requirements are met irrespective of country of designation.
• Ensuring I&J products are produced according to the relevant standards and regulations.
• Issue necessary guidelines to the Research and Development (R&D) and Marketing Teams alike.
• Product development in terms of regulatory requirements and compliancy
• Generating all ingredient declarations for the various products.
• Assists with completing Customer Specifications and ensuring they align with I&J specifications.
• Liaise with relevant accreditation bodies like Halaal, Beth Din, MSC, FOPL, ASC and more.
• Provides PDF copies of final product specifications when requested and if approved by Snr R&D Manager.
• Take ownership of the projects allocated to the Regulatory portfolio for example, actively manage and take accountability.

• Oversee the management of R&D Quality Manual and ensure R&D is updated & compliant with the latest versions of International Food Safety (IFS) and British Retail Consortium (BRC) certifications.
• Manage and co-ordinate internal audits of the R&D department.
• Act as representative for R&D on the I&J HACCP Management Team.
• Assist the Quality Assurance (QA) Team with internal audits when necessary.
• Ensuring all retail products are sent for nutritional analysis every 3 years.
• Ensuring GMO Free and any other relevant tests are completed as well as ensuring products are screened when required.
• Analysis: Maintenance of the Lab analysis cost spreadsheet of all products sent away for analysis.
• Vulnerability assessments: Keeping abreast of fraudulent, mislabeling and substitution occurrences for raw materials and ingredients by accessing various websites and subscribing to alerts.
• Conducts an annual Vulnerability Assessment review of all raw materials and ingredients together with Q.A., Procurement and Supplier Quality Assurance Departments.

• Keeping abreast of international and local legislation, guidelines, and customer practices.
• Escalating issues that may impact the I&J business to the Senior R&D Manager. Assist management to escalate issues through to the relevant local and global forums.
• Issue Regulatory Guidelines which will have an impact on the I&J business.
• Train the R&D and Marketing Teams on new legislation and inform the Quality Assurance department of new or amended regulations.

• Attend CGCSA FSI meetings and actively participate in working groups relating to the I&J business.
• SAMPA (SA meat processing association), attend the Annual General meeting.
• Keep informed of the working groups for relevant SA Legislation - Voluntary Standards and Compulsory Standards.
• Attend new local labelling regulations work groups.

• Minimum 5 years in a similar role within a food processing environment with regulatory experience

• Grade 12 / Matric
• National Higher Diploma in Food Technology or BSc Food Science qualification

• Experience of HACCP for Processors
• Completed IFS and BRC Training
• Understanding of ISO V5.1
• Available to work overtime when need be
• Own reliable transport

Job title : Regulatory Affairs Pharmacist

Job Location: Eastern Cape, Port Elizabeth

Deadline: October 02, 2025

• Preparing and submitting medicine registration applications for imported and locally made products in foreign countries.
• Maintaining existing product registrations in foreign countries.
• Responding to any deficiency letters or requests for information from the foreign countries.
• Checking of printed packaging specifications and proofs relevant to these registrations.
• Provision of product registration information on request by the Site Responsible Pharmacist and Export Marketing Managers.
• Assisting the Export Marketing Department with tender information relevant to the company.
• Preparing documents for international company registration in various territories.
• Maintaining the international registration product list.
• Assist with Batch Release when necessary.
• From time to time, carry out other jobs within the factory / department, consistent with the grade qualification and training of the incumbent.

• B. Pharm / Dip. Pharm.
• Registered Pharmacist with South African Pharmacy Council.
• 2-5 years Industrial Pharmaceutical Regulatory Affairs experience
• GMP, GWP and GDP Principles
• Understand quality investigation requirements (risk assessments, deviations, OOS, change controls)
• Pharmaceutical jobs

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous Regulatory Affairs Pharmacist to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Bachelors degree in pharmacy
• Pharmacist registration with SAPC

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• 5 years related experience in vaccine / biotech / pharmaceutical industry or equivalent
• Thorough knowledge of the current Medicines and Related Substances Act 101 and the Pharmacy Act 57 and current regulatory policies and guidelines of SAHPRA and their implication to the company.
• Experience in Pharmaceutical Regulatory Affairs aspects (Medicine registration and legal compliance) and documentation management and product maintenance related to the product portfolio
• Experience in quality and regulatory compliance within a cGMP facility.
• Program and project management
• Experience in registering product in ZAZIBONA /EAC-AMRH
• Experience in having faced successfully local and/ or international quality audits.
• Experience in eCTD compilation

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

• Maintenance and monitoring of existing registration dossiers (amendments and updates) including timeous responses to resolutions from NRAs by receiving and submitting all applicable updates, post-registration amendments, resolutions and any other correspondence required by the SAHPRA or any other applicable regulatory authority in accordance with current guidelines and within the specified timelines in order to support the strategic business objectives and close any compliance gaps as quickly as possible.
• Preparing and submitting post-registration clinical updates to package inserts and patient information leaflets in line with current SAHPRA guidelines and regulations.
• Perform due diligence audits of existing and new product regulatory dossiers.
• Author, compile, publish and submit new registration dossiers to NRAs in the required format for local (SA) and identified export markets for new products and when applicable work in conjunction with consultants to achieve submission.
• Completion of applicable Section 36 Exemption, Section 21 and Clinical Trial Applications.
• Update and maintain dossiers to latest requirements
• Identify key opportunities and deliverables as required by the department or by other departments for cross functional synergies/ project work.
• Provides regulatory advice when required to relevant stakeholders including sales, marketing, supply chain, medical and commercial team with regards to the products.
• Assist RA HOD in follow ups / responses on regulatory audits by third party / NRA
• Regulatory Intelligence: Assist RA HOD to Identify anticipated risks impacting department/ section/ team / keeping business abreast of regulatory developments, trends) and changes in the local regulatory and international environment which directly impacts Biovac products. Effectively communicating these changes so that all relevant stakeholders may assess the impact on the business.
• Request and obtain Import & Export Permits
• Writing / Reviewing and / updating of Regulatory SOPs (comprehensive and up to date and revised as per internal plan)
• Assist and or provide guidance in opening and close out of delegated Change Controls/ NCRs / CAPAs in order to support QAs processes.
• Review and approve artwork for packaging material to ensure compliance with regulatory requirements.
• Maintain and establish relationships with the SAHPRA units and/or other Health Authorities to ensure more effective streamlining of the companys applications when required
• Ensure that the Document Database is kept in good order by completing the required administrative activities for appropriate maintenance, co-ordination and accuracy of all dossiers and correspondence
• Approve promotional material (advertising)
• Assist in establishing the annual regulatory budget

Application Deadline: 15 August 2025

If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.

We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.

Disclaimer:

Dear Applicant, we appreciate your interest in joining our organisation. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.

Reference: DBN -SS-1
A global pharmaceutical company has a vacancy for a Regulatory Affairs Pharmacist to co-ordinate, project control and provide regulatory support for Central, East Africa and Mauritius countries.

Key Responsibilities:

• Keeping abreast of regulatory requirements in Central, East Africa and Mauritius countries.
• Ensure the completion of submissions/ variations according to Central, East Africa and Mauritius strategic plan and timelines.
• Drive registration/variation follow up strategies and find solutions to potential supply challenges.
• Ensure that labelling for Central, East Africa and Mauritius is compliant with in-country specific requirements.
• Ensure master product tracker is up to date and accurate at all times. Ensure alignment to all other trackers that are linked to the master.
• Conduct Due diligence activities.
• Co-ordinate and compile documentation for submission in Central, East Africa and Mauritius countries (New submissions/variations/RA documents) where required.
• Liaise and communicate with and support local agent in each country to meet regulatory requirements and timelines.
• Liaise and communicate with QA, Supply Chain and PV departments to ensure compliance and alignment with the various functions (including samples ordered for renewals, variations, and new submissions).
• Respond to product-specific queries from Central, East Africa and Mauritius countries where required.
• Co-ordinate internal back up and filing (electronic and hard copy) of dossiers and relevant communication.
• Download information from external portal i.e. Docubridge, sharepoint, we-transfer or regulatory drive.
• Arrange for translations of overseas documentation if required.
• Schedule Microsoft team meetings or teleconferences as needed.
• Conduct training sessions with Central, East Africa and Mauritius Team to ensure quality submissions in line with guidelines and upskilling of team members.
• Standardize folder structures and save information on NRD - Central, East Africa and Mauritius folder.
• Liaise with principals or the company with regards to outstanding information.
• Verify documents for completeness and current information.
• Compile and maintain spreadsheets and status reports as needed and upon request.
• Compilation of work map trackers to ensure visibility of tasks.
• Ensure Central, East Africa and Mauritius registrations are renewed in a timely manner and retention fees are paid as required.
• Assist with task risk management and compilation of risk plans when associated with submissions.
• Ensure the completion of all assigned Company training within the specified timelines.
• Forward all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.

• Must have a completed Bachelor of Pharmacy Degree and/or equivalent.
• 3-5 years’ experience in pharmaceutical industry (Regulatory Affairs/ Quality/ Production).
• Should have a sound knowledge of Sub-Saharan countries regulatory requirements and guidelines.
• Must have experience and understanding of electronic document management systems / eCTD.
• High level Computer literacy.
• People skills – highly adapted interpersonal skills.
• Problem solving analysis skills.
• Priority setting – initiative and follow through.
• Time management and ability to self-motivate.
• Strong attention to detail.
• Ability to work under pressure.
• Embodies Values & Behaviours in all internal and external interactions.

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on Should you receive no feedback within 7 days, please accept your application as unsuccessful.

• HR Services, Recruitment & Selection

Overview

Kenvue is recruiting in Cape Town, Western Cape, South Africa. We are a global company with iconic brands including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON’S and BAND-AID. We value science, care, insights and innovation.

Regulatory Affairs Contractor. Reports to the Head of Regulatory Operations, Scientific Affairs & External Engagement, SA-SSA. Location: Cape Town. Work Location: Hybrid.

This position reports into the Head of Regulatory Operations and is based in Cape Town. Travel: Minimal. Pay: 25.

To ensure regulatory compliance and operational efficiency by managing Legal Entity Name Change (LENC) artwork and labelling changes in accordance with global regulations. This role leads LENC regulatory submissions, change control, and compliance projects while providing strategic guidance across diverse product categories. Collaboration with cross-functional teams and external partners supports timely market access, brand consistency, and quality standards through effective execution of artwork development, documentation management, and continuous process improvement.

• Lead and manage Legal Entity Name Change (LENC) related end-to-end regulatory review and approval process for product artwork and labelling changes, ensuring full compliance with local and international regulations across pharmaceuticals, cosmetics, medical devices, and foodstuffs.
• Conduct regulatory impact assessments for proposed LENC changes, providing clear, actionable guidance to stakeholders to support decision-making and regulatory alignment.
• Prepare, submit, and maintain variations, amendments, and other post-approval regulatory submissions in accordance with internal quality systems and external regulatory requirements.
• Initiate, maintain, and monitor change control records, ensuring timely regulatory input and adherence to internal procedures and compliance standards.
• Coordinate cross-functionally with internal departments, including Marketing, Supply Chain, Quality Assurance, and Customer Services to align on timelines, gather key inputs, and ensure successful execution of regulatory and artwork projects.
• Oversee the full artwork development lifecycle from initial briefing to final approval and release, ensuring compliance with brand guidelines, regulatory standards, and customer specifications.
• Track and monitor artwork change progress, communicate status updates to relevant stakeholders, and proactively resolve any artwork- or packaging-related issues.
• Maintain accurate and up-to-date records, including artwork versions, regulatory approvals, and database entries, ensuring traceability and readiness for audits or inspections.
• Keep abreast of evolving regulations and guidelines relevant to all applicable product categories, ensuring the organization remains compliant with local, regional, and global requirements.
• Support the development and maintenance of Standard Operating Procedures (SOPs), and contribute to regulatory training initiatives for cross-functional teams.
• Provide regulatory insight and risk assessments in cross-functional project planning, offering guidance on feasibility, risk mitigation, and compliance considerations.

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field (mandatory).
• 1–3 years of experience in a Regulatory Affairs role, preferably within the pharmaceutical industry.
• Experience in regulatory processes for cosmetics, medical devices, and/or foodstuffs is highly desirable.
• Strong knowledge of change control, variation procedures, and product lifecycle management.
• Familiarity with global regulatory systems and guidelines (e.g., EMA, SSA and local authority regulations).
• Proven ability to manage multiple priorities and deliver within established timelines.

• Knowledge of consumer healthcare environment and product development.
• Understanding of processes and departments within a healthcare company.
• Effective time and organization management.

• Excellent attention to detail and organizational skills.
• Strong verbal and written communication abilities.
• Collaborative mindset with a proactive and solution-oriented approach.
• Ability to work effectively in a dynamic, cross-functional environment.
• Proficiency in MS Office and regulatory submission software/tools.

• Competitive Benefit Package
• Learning & Development Opportunities
• Kenvuer Impact Networks
• This list could vary based on location/region

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

• Entry level

• Part-time

• Legal

• Personal Care Product Manufacturing

Referrals increase your chances of interviewing at Kenvue by 2x

Cape Town, Western Cape, South Africa 4 days ago

Cape Town, Western Cape, South Africa 1 week ago

Technical and Quality Support Specialist roles in Cape Town are also noted; this article mentions an AI-assisted knowledge sharing context.

Product Compliance Specialist

Location:
Remote (South Africa)

Salary:
R30,000 - R40,000 per month

Our client, a leader in e-commerce consulting, is seeking a Product Compliance Specialist to join their compliance team.

You will ensure products meet regulatory standards across the UK and EU, providing expert advice on labelling, testing, ingredients, and manufacturing compliance for a diverse range of consumer products.

Key Responsibilities

• Manage and deliver compliance-based client services to ensure regulatory compliance
• Provide expert knowledge on products, ingredients, manufacturing standards, testing, and regulations.
• Liaise effectively with Trading Standards and European member states regarding consumer products manufactured and sold inside and outside the EU.
• Advise clients on labelling compliance and requirements across multiple product categories.
• Use EU and UK regulations to create detailed, professional compliance reports for clients.
• Keep up to date with regulatory changes and guidance from relevant agencies such as FSA, MHRA, and ESFA.
• Provide excellent customer service, ensuring responses and deliverables meet agreed SLAs.
• Support clients with technical documentation and complete product registrations for UK and EU markets, including cosmetics and medical devices.
• Conduct research on complex product categories, identifying trends and providing analysis.

Essential Qualifications & Skills

• A scientific degree in Environmental Science, Food Science, Cosmetics, Pharmaceuticals, Chemistry, or a related field
  (Essential)
• Proficiency with Microsoft 365.
• Strong attention to detail and organizational skills.
• Excellent communication and analytical abilities.

Preferred Skills

• Multilingual or bilingual proficiency in
  French, German, Spanish, or English
  .

If you want to develop in an industry-leading international environment, this role is for you

Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide.

We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.

The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.

The main purpose of the Regulatory Affairs Pharmacist to prepare and submit medicine registration applications to various regulatory authorities outside South Africa in accordance with regulatory requirements of the relevant country. To maintain these registration applications subsequent to registration approval.

General Duties:

• Preparing and submitting medicine registration applications for imported and locally made products in foreign countries.
• Maintaining existing product registrations in foreign countries.
• Responding to any deficiency letters or requests for information from the foreign countries.
• Checking of printed packaging specifications and proofs relevant to these registrations.
• Provision of product registration information on request by the Site Responsible Pharmacist and Export Marketing Managers.
• Assisting the Export Marketing Department with tender information relevant to the company.
• Preparing documents for international company registration in various territories.
• Maintaining the international registration product list.
• Assist with Batch Release when necessary

• From time to time, carry out other jobs within the factory /department, consistent with the grade qualification and training of the incumbent.

• B. Pharm / Dip. Pharm.

• Registered Pharmacist with South African Pharmacy Council.
• 2-5 years Industrial Pharmaceutical Regulatory Affairs experience
• GMP, GWP and GDP Principles
• Understand quality investigation requirements (risk assessments, deviations, OOS, change controls)